Rapidscan Pharma Solutions EU Ltd Selects GE Healthcare to Promote and Distribute Rapiscan(R) (regadenoson) in the United Kingdom and Germany

LONDON, May 12, 2011 /PRNewswire/ -- Today Rapidscan Pharma Solutions (RPS) EU Ltd reports that they have come to agreement with GE Healthcare to promote and distribute Rapiscan(R) (regadenoson) in the United Kingdom and Germany. Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging in adult patients unable to undergo adequate exercise stress in the diagnosis of coronary artery disease (CAD) - the single most common cause of death and disability in Europe.(1)

Rapiscan is administered as a non-weight based bolus injection and is the first and only selective A2A adenosine receptor agonist to have a licence for use in this indication.

Diagnosis of CAD uses Myocardial Perfusion Imaging (MPI), to identify areas of poor blood flow in the heart at rest and during exercise. MPI is a non-invasive diagnostic test where patients are commonly asked to exercise on a treadmill or bicycle. Images are created with a small amount of a radioactive substance, called a radiopharmaceutical, which shows how well blood flows to the muscle of the heart.

Unfortunately, nearly half of all patients that require a MPI diagnostic test are unable to exercise adequately. Rapiscan provides an option for these patients by simulating the effects of exercise by temporarily increasing blood flow through the arteries of the heart and increasing heart rate. Unlike older agents, Rapiscan requires no dose adjustment for varying body weight2 and its bolus dosing method is rapid (taking just 10 seconds), cutting out the need for an infusion pump and it's set-up. Beyond the practical benefits, Rapiscan selectively stimulates the A2A adenosine receptors responsible for the increase in blood flow, but not other adenosine receptors believed to cause undesirable effects that have been associated with the existing pharmacological stress agents.(2,3)

Founder, President and CEO of Rapidscan Pharma Solutions Dr Brent Blackburn commented, "I am pleased to be able to partner with GE Healthcare. We share a common objective - each striving to improve patient healthcare by the timely and accurate diagnosis of disease with products with improved tolerability and that are easier to use. Rapiscan was designed to specifically address the needs of patients and healthcare professionals who conduct MPI tests and GE Healthcare is uniquely situated as a leader in the field of cardiac imaging and molecular diagnostics to efficiently introduce Rapiscan to the UK and German healthcare communities."

Stephen Lightfoot, Global MI-SPECT Segment Leader, Medical Diagnostics, GE

Healthcare said "The opportunity to launch Rapiscan with Rapidscan Pharma Solutions EU leverages the expertise and unique capabilities of both organizations - to bring an important product used for the diagnosis of coronary artery disease to the UK and German marketplace."

Every year more than 4 million Europeans die from diseases of the heart and blood vessels,(1) accounting for almost half of total mortality in Europe.(1) Accurate diagnosis is vital in identifying patients who are appropriate for intensive medical intervention with more than 1.5 million Europeans undergoing MPI tests annually.

Regadenoson was launched in the US in 2008 following clinical trials of over 2,000 patients with known or suspected CAD.(1,4,5) Today, regadenoson is currently the most widely used pharmacological stress agent in the US with several million patients having received it.

Notes to Editors:

More about regadenoson

Regadenoson is a selective A2A adenosine receptor agonist approved as a pharmacological stress agent in radionuclide MPI, in adult patients unable to undergo adequate exercise stress. Regadenoson was discovered and developed by CV Therapeutics and was approved by the FDA in April 2008, where it is sold by Astellas Pharma US. Gilead Sciences acquired CV Therapeutics in 2009. EU Commission Licence was granted by the European Medicine Agency in September 2010.

About Rapidscan Pharma Solutions (RPS)

Its President and CEO Dr Brent Blackburn and his co-founders Dan Spiegelman and Louis G Lange, MD, PhD, established U.S.-based Rapidscan Pharma Solutions (RPS) Inc in 2010. RPS Inc has licenced the rights to develop, make, and sell regadenoson from Gilead Sciences Inc for Europe, Latin America, Japan, Australia, New Zealand, and Israel. Its European affiliate, RPS EU Ltd received marketing authorization for Rapiscan in January 2011 in the European Union. Dr Blackburn was previously with CV Therapeutics and was a leading member of the team that discovered and developed regadenoson in the U.S. and Europe.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at http://www.gehealthcare.com.

References:

1. Scholte op Reimer WJM, Gitt AK, Boersma E, Simoons ML (eds.). Cardiovascular Diseases in Europe. Euro Heart Survey - 2006. Sophia Antipolis; European Society of Cardiology; 2006

2. Rapiscan Summary of Product Characteristics. Rapidscan Pharma Solutions EU Ltd. March 2011. See http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001176/human_med_001378.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125

3. Buhr C, Gössl, M, Erbel R, Eggebrecth H "Regadenoson in the detection of coronary artery disease" Vasc Health Risk Manag. 2008;4(2):337-40.

4. Cerqueira MD, Nguyen P, Staehr P, et al, on behalf of the ADVANCE MPI Trial Investigators. Effects of age, gender, obesity and diabetes on the efficacy and safety of the selective A2A agonist Rapiscan versus adenosine: integrated ADVANCE MPI trial results. J Am Coll Cardiol 2008;1:307-316.

5. Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus Rapiscan comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol 2007;14:645-658.

(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)

Prescribing information is available upon request.